KCT0004959终止未知
Combination of SGLT2 inhibitor and DPP-4 inhibitor as add-on therapy in subjects with type 2 diabetes inadequately controlled on insulin combined with metformin + DPP-4 inhibitor or metformin + SGLT2 inhibitor or metformin : open-label, multicenter trial
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •(1) Diagnosed with type 2 diabetes (according to the American diabetes association standard) by a blood test
- •(2) Patients using basal insulin and metformin at least 1,000 mg / day with stable volume for at least 8 weeks before Visit 1 (Screening)
- •(3) Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 12%
- •(4) 18 Years to 74 Years (Adult)
- •(5) Body mass index of 20 through 35 kilogram per meter square (kg/m^2)
- •(6) Estimated glomerular filtration rate (eGFR) of at least 45 milliliter/minute (mL/min)/1.73 meter square (m^2)
- •(7) Basal C-peptide level or more 1.0ng/ml
排除标准
- •(1) Patient with hypersensitivity reaction to the drug in this study or a drug containing a homologous system (eg, a history of hypersensitivity to SGLT2i or DPP4i)
- •(2) Have the following medical history or history of surgery / treatment
- •-Type 1 diabetes
- •-Diabetic ketone acidosis at screening
- •-Diabetic coma or pre-coma at screening
- •-Experience cardiovascular events (acute coronary artery disease, cerebral infarction, transient ischemic attack) within 3 months of screening criteria
- •-Patients diagnosed with solid or blood cancers and are or are planning to be treated
- •-Past history of acute pancreatitis
- •-Urinary tract or genital infections within the last year
- •-Suspected alcohol abuse
- •- (3) have the following diseases or signs
- •-Patient determined to require continuous systemic steroid treatment at screening
- •-Severe Infectious Disease, Before and After Surgery, Severe Trauma
- •-Symptoms of urination disorder, urination, hematuria, urinary tract that are not controlled by drugs due to tension incontinence, neurogenic bladder, and enlarged prostate.
- •-Pregnant and lactating women (for women of childbearing age, urine ß-hCG test at the time of registration)-Persons suspected of alcohol abuse
- •Unstable mental illness with no controlled symptoms. Uncontrolled hyperglycemia> 270 mg / dl (after 8 hours fasting)
- •-Those who complain of weight loss of 10% within 3 months with polyphagia,polyuria, polydipsia at screening
- •-Severe liver dysfunction (over 3 times normal range of liver function test AST, ALT, ALP)
- •-Severe heart failure (New York Heart Association Class II or higher)- Severe Inflammatory disease, Severe trauma after surgery
- •(4) Genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
- •(5) Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at Screening(However, if no medication has been taken due to observational research, participation in this clinical trial is possible.)
- •(6) For other reasons Determines that the investigtor is not suitable for participation in the clinical trial.
研究者
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